DOP2004000994A - SUBSTITUTED HETEROCICLIC INDANO DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CHICHOPHRENIA. - Google Patents

SUBSTITUTED HETEROCICLIC INDANO DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CHICHOPHRENIA.

Info

Publication number
DOP2004000994A
DOP2004000994A DO2004P000994A DO2004000994A DOP2004000994A DO P2004000994 A DOP2004000994 A DO P2004000994A DO 2004P000994 A DO2004P000994 A DO 2004P000994A DO 2004000994 A DO2004000994 A DO 2004000994A DO P2004000994 A DOP2004000994 A DO P2004000994A
Authority
DO
Dominican Republic
Prior art keywords
azithromycin
oral
azitromycin
effective amount
dosage form
Prior art date
Application number
DO2004P000994A
Other languages
Spanish (es)
Inventor
Timothy Arthur Hagen
Scott Max Herbig
Julian Belknap Lo
Avinash Govind Thombre
Leah Elizabeth Appel
Marshall David Crew
Dwayne Thomas Frisen
David Keith Lyon
Scott Baldwin Mccray
James Blair West
Original Assignee
Pfizer Prod Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34468055&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DOP2004000994(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pfizer Prod Inc filed Critical Pfizer Prod Inc
Publication of DOP2004000994A publication Critical patent/DOP2004000994A/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00Antiparasitic agents
    • A61P33/02Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)

Abstract

UNA FORMA DE DOSIFICACION ORAL QUE COMPRENDE AZITROMICINA Y UNA CANTIDAD EFICAZ DE UN AGENTE ALCALINIZANTE. PREFERIBLEMENTE, DICHA FORMA DE DOSIFICACION ORAL COMPRENDE UNA CANTIDAD EFICAZ DE UN AGENTE ALCALIRIIZANTE Y UN MULTIPARTICULADO DE AZITROMICINA EN EL QUE DICHO MULTIPARTICULADO COMPRENDE AZITROMICINA, UNA MEZCLA DE MONOBEHENATO DE GLICERILO, DIBEHENATO DE GLICERILO Y TRIBEHENATO DE GLICERHO Y UN POLOXAMERO. TIPICAMENTE, LA FORMA DE DOSIFICACION ORAL INCLUYE CUALQUIER MEDIO DE ADMINISTRACION ORAL ADECUADO TAL COMO UN POLVO PARA SUSPENSION ORAL, UN ENVASE O SOBRECITO DE DOSIS UNITARIA, UN COMPRIMIDO O UNA CAPSULA. EMAS SE DESCRIBE UNA SUSPENSION ORAL QUE COMPRENDE AZITROMICINA, UNA CANTIDAD EFICAZ DE UN AGENTE ALCALINIZANTE Y UN VEHICULO. PREFERIBLEMENTE, LA AZITROMICINA ESTA EN FORMA MUITIPARTICULADA EN LA QUE DICHO MULTIPARTICULADO COMPRENDE AZITROMICINA, UNA MEZCLA DE MONOBEHENATO DE GLICERILO, DIBEHENATO DE GLICERILO Y TRIBEHENATO DE GLICERILO Y UN POLOXAMERO. MBIÉN SE DESCRIBE UN PROCEDIMIENTO PARA REDUCIR LOS EFECTOS SECUNDARIOS GASTROINTESTINALES ASOCIADOS A LA ADMINISTRACION DE AZITROMICINA A UN MAMIFERO, QUE COMPRENDE LA ADMINISTRACION DE FORMA CONTIGUA DE AZITROMICINA Y UNA CANTIDAD EFICAZ DE UN AGENTE ALCALINIZANTE A DICHO MAMIFERO EN EL QUE LA FRECUENCIA DE EFECTOS SECUNDARIOS GASTROINTESTINALES ES MENOR QUE LA QUE SE EXPERIMENTA ADMINISTRANDO UNA DOSIS IGUAL DE AZITROMICINA SIN DICHO AGENTE ALCALINIZANTE. ADEMAS SE DESCRIBE UN PROCEDIMIENTO PARA TRATAR UNA INFECCION BACTERIANA O PROTOZOARIA EN UN MAMÍFERO QUE LO NECESITE QUE COMPRENDE LA MINISTRACIÓN DE FORMA CONTIGUA A DICHO MAMÍFERO DE UNA DOSIS ÚNICA DE UNA FORMA DE DOSIFICACIÓN ORAL EN LA QUE DICHA FORMA DE DOSIFICACIÓN ORAL COMPRENDE AZITROMICINA Y UNA CANTIDAD EFICAZ DE UN AGENTE ALCALINIZANTE. ICIONALMENTE SE DESCRIBEN MULTIPARTICULADOS DE AZITROMICINA QUE COMPRENDEN AZITROMICINA, UN TENSIOACTIVO; Y UN VEHÍCULO FARMACÉUTICAMENTE ACEPTABLE.AN ORAL DOSAGE FORM THAT INCLUDES AZITHROMYCIN AND AN EFFECTIVE AMOUNT OF AN ALKALINIZING AGENT. Preferably, said oral dosage form comprising an amount EFFECTIVE AND AN AGENT ALCALIRIIZANTE azithromycin multiparticulate wherein said multiparticulate comprising azithromycin, a mixture of monobehenate glyceryl dibehenate, glyceryl tribehenate GLICERHO and a poloxamer. Typically, the ORAL DOSAGE FORM INCLUDES ANY MEANS OF ADEQUATE ORAL ADMINISTRATION SUCH AS A POWDER FOR ORAL SUSPENSION, A PACKAGE OR OVERHEAD OF UNITARY DOSE, A COMPRESSED OR A CAPSULE. EMAS DESCRIBES AN ORAL SUSPENSION THAT INCLUDES AZITHROMYCIN, AN EFFECTIVE AMOUNT OF AN ALKALINIZING AGENT AND A VEHICLE. PREFERIBLY, AZYTHROMYCIN IS IN A MULTIPARTICULATED FORM IN WHICH SUCH MULTIPARTICULATE INCLUDES AZYTHROMYCIN, A MIXTURE OF GLYCERYLL MONOBEHENATE, GLYCERHYL DIBEHENATE AND A POLYXYLENE TRIBEHENATE. A PROCEDURE TO REDUCE THE GASTROINTESTINAL SECONDARY EFFECTS ASSOCIATED WITH THE ADMINISTRATION OF AZITROMYCIN IS DESCRIBED TO A MAMPHERE, WHICH UNDERSTANDS THE ADMINISTRATION IN A CONDITIONAL FORM OF AZITROMYCIN AND AN EFFECTIVE AMOUNT OF A MANUFACTURER HAS BEEN AFFECTED BY THE AGENT. IT IS LESS THAN THAT EXPERIENCED BY ADMINISTRATING AN EQUAL DOSE OF AZITHROMYCIN WITHOUT SUCH ALKALINIZING AGENT. IN ADDITION, A PROCEDURE IS DESCRIBED TO TREAT A BACTERIAL OR PROTOZOARY INFECTION IN A MAMMERE THAT NEEDS IT TO UNDERSTAND THE MINISTRATION CONCERNS SUCH MAMMER OF A SINGLE DOSE OF AN ORAL DOSAGE FORM IN WHICH DIFFERMS AN ORAL FORM EFFECTIVE AMOUNT OF AN ALKALINIZING AGENT. MULTIPARTICULATED AZITROMYCIN MULTIPARTICULATES THAT INCLUDE AZITROMYCIN, A TENSIOACTIVE, ARE DESCRIBED; AND A PHARMACEUTICALLY ACCEPTABLE VEHICLE.

DO2004P000994A 2003-12-04 2004-09-09 SUBSTITUTED HETEROCICLIC INDANO DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CHICHOPHRENIA. DOP2004000994A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US52708403P 2003-12-04 2003-12-04
US10/763,340 US6984403B2 (en) 2003-12-04 2004-01-23 Azithromycin dosage forms with reduced side effects

Publications (1)

Publication Number Publication Date
DOP2004000994A true DOP2004000994A (en) 2005-06-30

Family

ID=34468055

Family Applications (1)

Application Number Title Priority Date Filing Date
DO2004P000994A DOP2004000994A (en) 2003-12-04 2004-09-09 SUBSTITUTED HETEROCICLIC INDANO DERIVATIVES AND RELATED COMPOUNDS FOR THE TREATMENT OF CHICHOPHRENIA.

Country Status (36)

Country Link
US (4) US6984403B2 (en)
EP (1) EP1537859B1 (en)
JP (2) JP4602711B2 (en)
KR (1) KR100906290B1 (en)
AR (1) AR045630A1 (en)
AT (1) ATE407663T1 (en)
BR (1) BRPI0403935B8 (en)
CA (1) CA2467611C (en)
CL (1) CL2004001501A1 (en)
CR (1) CR7500A (en)
CY (1) CY1108486T1 (en)
DE (1) DE602004016444D1 (en)
DK (1) DK1537859T3 (en)
DO (1) DOP2004000994A (en)
EA (1) EA010110B1 (en)
ES (1) ES2312929T3 (en)
GE (1) GEP20074056B (en)
HK (1) HK1080367B (en)
HR (1) HRP20040865A2 (en)
IL (1) IL164165A (en)
IS (1) IS2672B (en)
MA (1) MA27848A1 (en)
MX (1) MXPA04009424A (en)
NL (1) NL1026315C2 (en)
NO (1) NO20043903L (en)
NZ (1) NZ535464A (en)
OA (1) OA12858A (en)
PA (1) PA8611501A1 (en)
PE (1) PE20050573A1 (en)
PL (2) PL1537859T3 (en)
PT (1) PT1537859E (en)
RS (1) RS84704A (en)
SI (1) SI1537859T1 (en)
TW (1) TWI351969B (en)
UY (1) UY28509A1 (en)
WO (1) WO2005053650A1 (en)

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